EDMA News Update 29
HIGHLIGHT ON
Labtestsonline.es is now online, offering all Spanish speakers a comprehensive and clear online source of information on clinical laboratory testing.
Adhering to the same non-commercial and peer-review policies that have made Lab Tests Online a success in the United States and the United Kingdom, the Spanish version provides already access to 74 parameters, explaining in detail the various tests and samples, the associated conditions and the most frequent questions. New tests, conditions and screening programmes will be added on a regular basis.
Lab Tests Online ES is the result of an agreement signed between the American Association for Clinical Chemistry (AACC) and EDMA to translate and adapt the content of the US website Lab Tests Online to European countries. The Spanish site has been developed by the Sociedad Española de Bioquímica Clínica y Patologia Molecular (SEQC) in cooperation with Fenin, the national Medical Technology association member of EDMA. The Spanish version, joining the British and American sites, will “extend beyond borders and be a great asset (also) to Spanish speakers in Latin America and in the U.S.” declared AACC President Gary L. Myers in his Congratulations Letter to EDMA President Jean-François de Lavison.
In the coming months, four new Lab Tests Online versions, with original material of particular relevance in these countries, will be available in German, Polish, Italian and Hungarian. All sites are developed in close cooperation by the national diagnostics associations affiliated to EDMA and professional users’ societies.
EDMA MEMBERSHIP
MLT Research joins EDMA
EDMA welcomes MLT Research Ltd. as new corporate affiliate, bringing its overall membership up to 27 major IVD companies and 20 National Associations. MLT is a pioneer in the development of highly sensitive diagnostic tests employing molecular technologies including chemiluminescence. This technology has had an enormous impact on clinical diagnostic test methods, developing numerous analytical test products which are used in a diverse range of applications from the measurement of hormones to the detection of micro-organisms. EDMA is looking forward to a fruitful cooperation with MLT to promote In Vitro testing, prevention, early diagnosis and monitoring of treatments, access to innovation, and high quality healthcare.
REGULATORY AFFAIRS NEWS
Global Regulatory Issues Discussion Forum
The fifth EDMA Regulatory Affairs Discussion Forum, held on 2 March in Brussels and attended by about 50 participants, focused on ‘Global Regulatory Issues -. IVD companies working in an international environment.’ 18 Corporate members (out of 27) were represented, of which 7 newcomers; as well as companies affiliated to the National Associations in Italy (Assobiomedica), UK (BIVDA), Hungary (HIVDA), France (SFRL), and Sweden (SINDIF).
The timing was opportune: in China, India, Brazil, Australia and Russia the legislation is currently under revision. The participants were informed of the current regulatory status in 8 countries (the aforementioned countries and also Singapore, Malaysia and Japan) as well as provided an overview of the work of the EDMA Globalisation TF and information on Global Harmonisation Task Force (GHTF) activities. Presentations were given by Hubert Bayer (Roche), Bernard Fleury (bioMerieux), Karen Howes (EDMA Regulatory Director), Thomas Mall (Roche), Benny Ons (BD, EDMA Treasurer) and Irene Schmidt (Dade Behring). Each presentation was followed by a lively discussion with much interest being shown in Chinese and Japanese activities. In his concluding remarks, Benny Ons noted the interest shown in having regulatory information available on further countries including Argentina, Columbia, Turkey, Egypt, Ghana and Saudi Arabia, as well as the possibility to have further discussions on the current work in GHTF study group 1 on IVD conformity assessment and classification. Details of the discussion forum including presentations and the evaluation form are available on the EDMA website .
The discussion forum was also an opportunity to showcase the recently published ‘country regulatory information’ on 10 non EU countries; Australia, Brazil, China, Japan, Korea, Malaysia, Mexico, Singapore, Taiwan and Thailand, and now available via the EDMA website. EDMA Globalisation task force members are thanked for their work in the planning and delivery of the discussion forum and the generation of the country regulatory information.
European Commission consultation on metrication (dual labelling)
The European Commission launched a consultation on the units of measurement Directive 80/181/EEC in December 2006, which was open until 1 March 2007. In the context of a revision of the Directive, the consultation focused on the extension of the SI system and the provision for the use of supplementary units (dual labelling SI and non SI) that ends in December 2009. EDMA worked together with its members to provide a response that pointed out the many benefits in maintaining the status quo and the risks associated with the potential exclusion of non SI units.
EDMA supports the Medical Device & Diagnostics Summer School
Taking place on 17-19 July in Cambridge University (UK), the summer school will provide a step-by-step guide to the industry, guiding attendees through the basic knowledge and developing their skills to understand how the recent regulatory changes will impact their daily work. Through in-depth tutorials with industry leaders and interactive, practical sessions, this event will focus on the key requirements for a successful career in the medical device industry. Ben Jacoby, member of the EDMA Regulatory Affairs Committee and responsible for International Regulatory Affairs at Ortho-Clinical Diagnostics, will present “IVD devices and associated regulations”. EDMA members who would like to attend are invited to quote CQ2142EDMA to save up to £200 if booking before 20 April. For more information please visit the event’s website
PUBLIC AFFAIRS NEWS
EDMA and ESCMID building bridges
On 14 March, EDMA met in Brussels with the European Society of Clinical Microbiology & Infectious Diseases, represented by its President-elect, Giuseppe Cornaglia and its Scientific Officer, Jordi Vila. The objective of this first meeting was to discuss the creation of a partnership to promote together the In Vitro Diagnostics in the field of Microbiology and their valuable contribution to fight Infectious Diseases. Patricia Noterman (Public Affairs TF chair, Dade Behring), Werner Majunke (Value of IVDs TF chair, Roche), Ivo Steenackers (Nosocomial Infections Team coordinator, BD) and Gloria Galán (EDMA Communications & PA Manager) presented the work of the respective working groups within EDMA. A second event will take place by mid-April to match common priorities and agree on a concrete joint action plan.
Early Diagnosis & Early Treatment: Keys to reduced HIV transmission
The ECDC technical report “HIV-Infection in Europe: 25 years into the Pandemic”, prepared as background information for conference organised by the German Presidency of the EU in Bremen on 12-13 March ("Responsibility and Partnership - Together against HIV/Aids"), states that the current spread of infections calls for increased prevention and earlier treatment to contain the disease. EDMA believes that it should be possible and beneficial to identify the main objectives of a strategy to increase earlier detection of HIV infected persons in Europe. Key elements for such EU-wide strategy, which could take the form of a Council recommendation, should include targeted testing on the basis of risk behaviours and preconception care, improvement of the access to routine HIV testing of migrants from countries with generalized HIV epidemic and introduction of routine targeted testing of new subgroups of high risk individuals. The AIDs pandemic prophesied by the ECDC will meet no barriers in Europe. For that reason, EDMA advocates that HIV can be detected by reliable, inexpensive, and non-invasive screening tests.
INNOVATION AND RESEARCH
EU – US Economical Gap Widens
A study by Eurochambres, the Association of European Chambers of Commerce and Industry, recognises the current economic upswing, but states that the EU is still losing ground compared to its global competitors – in particular with its current level of investment in R&D already reached by the United States almost 30 years ago. Both the current EU levels for employment and R&D investment per capita were reached by the US in 1978. Eurochambres calls for the creation of the long-awaited European Institute of Technology to support innovation, and an essential role for SMEs in the development of this new EU body.
FP7 Funding Opportunities
The 7th Framework Programme (FP7) for Research & Development has issued two calls for action concerning researchers’ training. The Marie Curie Intra-European Fellowships for Career Development support the development of experienced researchers at different stages of their careers, and seeks to enhance their individual competence diversification in terms of skill acquisition at multi- or interdisciplinary level and/or by undertaking intersectoral experiences. The deadline for application is 14 August 2007. A Guide for Applicants is available to those of our members that would like to apply.
NEWS FROM THE NAMS
EDMA visits VDGH, Fenin and pharma.be Diagnostics
Since the beginning of 2007, Jean-François de Lavison, EDMA President and Christine Tarrajat, EDMA Director General have met with several National Association Members: after the meetings with VDGH Board in Germany on 1 February and with Fenin Board in Spain on 7 March, they were invited to the General Assembly of pharma.be Diagnostics in Belgium on 9 March. Meeting our members is always a good opportunity to exchange information about the latest EDMA and NAMs activities, to dialogue about the future possibilities of collaborative efforts and to answer to the various questions of the members, regarding some recent regulatory developments (Supply of Instructions For Use by other means or EDMA influence outside of Europe, e.g. in China) and the latest news on the two websites MedicalLab, now also online in French, and Lab Tests OnLine, recently launched in Spanish.
EDMA visit to BIVDA Regulatory Affairs WP
Jesús Rueda, EDMA Regulatory Affairs Manager, participated at the BIVDA Regulatory Affairs WP meeting on 9 March 2007. The meeting was packed with eager attendees and a broad range of topics were covered, ranging from issues relating to the MHRA, import and export problems, and topics with a European dimension to which EDMA contributed such as REACH, Animal by Products legislation and updates on a number of standardization activities. The meeting was followed by a session of informal discussions where individual BIVDA members freely exchanged all manner of information in a friendly atmosphere. Our thanks to Doris Ann Williams for this gracious invitation.
MEETINGS & EVENTS
Updated list of forthcoming EDMA meetings
Check the calendar of relevant events to the IVD industry. Latest entries:
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4-7 Sep. Antalya, XV Congress of the Balkan Clinical Laboratory Federation
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26-28 Mar. Barcelona, World Health Care Congress Europe 2007.
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29 Mar. Brussels, European Patients' Rights Day